An IVD Medical Device is defined in the IVDR as “any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body.

In vitro diagnostics (IVDs) are tests that can detect disease, conditions and infections. In vitro simply means 'in glass', meaning these tests are typically conducted in test tubes, cassettes and similar equipment, as opposed to in vivo tests, which are conducted in the body itself.

The IVDR is the new regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market. It will replace the EU’s current Directive on in vitro diagnostic medical devices (98/79/EC). As a European regulation, it will be effective in all EU member states and EFTA states immediately without need to be transferred into the law of respective states, however national laws may be adapted to back up some requirements in more detail.

The IVDR came into force on 25 May 2017. Several implementing acts/guidance documents are being issued by the EU commission and are stipulated to complete some of the requirements to be met.

All the usual methods of communication can be used, phone, email, and the contact form on the website. Whichever method suits your needs best, check out the website footer for our contact information. Additionally if you need a face to face meeting we are more than happy to come visit.

Hygiene UK offer next day delivery, when ordering before 12pm on the day of ordering. If we can fast track your order, let us know your timescales and we'll endeavour to assist you.

Hygiene UK source products from across the globe. Where possible we keep the delivery miles to minimise the environmental impact.

Depending on whether you work in a medical facility, an industrial environment, or are a member of the general public, we'll help determine the type of mask you need. Please contact us for advice.

PPE is the acronym for Personal Protective Equipment, which is used to protect and shield an individual from infection or injury. This can include gloves, masks, aprons, gowns, coveralls and face shields.

The purpose of a face mask, such as Type I, Type IR, Type II or Type IIR, is to protect others from the wearer transmitting infection. Whereas respirator masks, such as FFP2 and FFP3, are effective at protecting the wearer from viral transmission.

Type I and Type IR face masks have a bacterial filtration efficiency (BFE) of 95%, however Type II and Type IIR facemasks have a BFE of 98%. Medical face masks such as Type I, IR, IIR are tested for direction of exhalation (inside to outside) and it takes the efficiency of bacterial filtration. Wearing masks of this type prevent the user from infecting the surrounding environment, however, they are not effective at protecting the wearer from airbourne diseases, such as COVID19.

Type II face masks are compliant with EN14683 standards, these medical face masks are made up of a protective 3PLY construction that prevents large particles from reaching the user or surfaces, however, they are not effective when blood or bodily fluids are present.

Type IIR face masks are complaint with EN14683 standards, and are known to be the model used widely in surgical environments. They have a splash resistant layer to protect against blood and bodily fluids.

FFP2 masks are European classed respirators, which meet The World Health Organisation (WHO) guidelines for protection against COVID-19. FFP2 masks have a filtration greater than 94% and maximum of 8% leakage to the inside.

FFP3 are European classed respirators which have the most effective filtration, with a minimum of 99% and maximum leakage of 2% to the inside. They tend to have a more ergonomic fit to the face and can have a exhalation valve to help breathe / reduce moisture build up on the inside as the filtration material is much thicker.

N95 face masks are not legal for use in Europe or the EU.

Disposable Gloves such as vinyl, nitrile or synthetic are usually available in Extra Small (XS), Small (S), Medium (M), Large (L), or Extra Large (XL). Some sizing may vary with manufacturer makes. Our gloves have a size guide on the back of the boxes. But as a general guide, you measure the palm of the hand, from the base of the little finger across to the side of the thumb. Upto 7.3cm = XS, 7.3 - 8.3cm = S, 8.1 - 8.9cm = M, 8.9 - 10.2cm = L, 9.9 - 11.2 cm = XL. Gloves need to fit well but too small and they will split or break, so best to try for the correct fit.